Clinical Trial Operations Specialist

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 94,000 - 153,000; Full time

Benefits offered by this job

Health & wellness programs

Fitness centers

Insurance benefits (medical, dental,视觉

Paid time off

Family support benefits

401(k) company match

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to support trial management from site activation through close-out. The role collaborates with clinical leads, study teams, CROs, and sites to maintain study timelines and data quality.

Location: Armonk, NY or Warren, NJ; primarily on-site with hybrid flexibility. Requires 2+ years in a clinical setting and familiarity with trial management systems.

Qualifications

• Bachelor's degree with 2+ years of industry‑related work experience in a clinical setting.
• Ability to acquire working knowledge in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF)
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP
• Proactive, self‑disciplined, and effective at managing deadlines and priorities

Responsibilities

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes
• Collates data for feasibility and site selection assessments, and contributes to review of study documents (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
• Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance
• Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally
• Contributes to close‑out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close‑out visits) and supports oversight of third‑party vendors as needed
• Brings attention to detail, resourcefulness, and proactive problem‑solving to assigned study activities, investigating impact on trials as new information arises
• Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

Skills

Trial management systems & MS Office

Medical terms familiarity

ICH/GCP awareness

Deadline & priority management

Education

Bachelor's degree in a relevant field

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to support trial management from site activation through close-out. The role collaborates with clinical leads, study teams, CROs, and sites to maintain study timelines and data quality.

Location: Armonk, NY or Warren, NJ; primarily on-site with hybrid flexibility. Requires 2+ years in a clinical setting and familiarity with trial management systems.